FDA panel backs broader use of Edwards heart valve

A panel of heart experts said Wednesday that the government should expand approval of the first artificial heart valve designed to be implanted without major surgery, despite limited information about some long-term side effects.

The Food and Drug Administration's panel of outside cardiologists voted 11-0 with one abstention that the benefits of broader approval for Edwards Lifesciences' Sapien valve outweigh the risks.

The valve is currently approved for patients who aren't healthy enough to undergo the more invasive open-heart surgery, which has been used to replace the aortic valve for decades.

If FDA follows the group's advice, the implant will be approved for patients who are healthier, but still face serious risks from chest-opening surgery. Many such patients are in their 80s and have complicating medical factors like diabetes.

The FDA is not required to follow the panel's advice, though it often does. A decision is expected later this year.

Edwards Lifesciences Corp. presented data from a pivotal trial showing that patients implanted with its heart valve survived about as long as those who underwent surgery. One year after the operation, 76 percent of patients implanted with the heart valve were still alive, compared with 73 percent of those who had undergone open-heart surgery.

The numbers were close enough to meet the study's goal of showing that Sapien's survival rate was at least as good as surgery. But panelists raised a number of concerns about the valve's side effects and the accuracy of the company's trial results.

Patients who got the Sapien valve had a higher rate of stroke immediately following the procedure when compared to surgery, though rates evened out over time. Additionally, more than half of patients had leaking from the aortic heart valve, a potentially dangerous condition in which blood flows backward into the heart's ventricle chamber.

Elsewhere, panelists noted that the death rate among men was more than 3 percent higher than that for women with the Sapien valve.

In each case, panelists said more follow-up data would be needed to define the scope and severity of these issues.

Irvine, Calif.-based Edwards plans to conduct two follow-up studies to evaluate long-term safety as well as differences in gender outcomes.

About 300,000 U.S. patients suffer from deterioration of the aortic heart valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients diagnosed with the condition, called aortic stenosis, die within two years, according to the FDA.

Every year about 50,000 people in the U.S. undergo open-heart surgery to replace the valve, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place. Thousands of other patients are turned away, deemed too old or ill to survive the operation.

The Sapien valve is usually threaded through the femoral artery via a small incision in the leg, and then guided up to the heart via catheter. An alternate procedure inserts the valve through a small incision between the ribs. The valve is then wedged into the aortic opening by an inflatable balloon, replacing the natural heart valve. The device is made from cow tissue and polyester supported by a steel frame.

Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve.

In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

Shares of Edwards Lifesciences Corp. fell 27 cents Wednesday to close at $90.54. They rose 59 cents to $91.13 in extended trading following news of the panel's vote.

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U.S. advisers back Edwards valve for wider group

Reuters – 4 hrs ago GAITHERSBURG, Maryland (Reuters) - An artificial heart valve from Edwards Lifesciences Corp that can be inserted without cracking open the chest for surgery won the support of U.S. advisers on Wednesday for use in a wider group of patients.

A panel of outside advisers to the U.S. Food and Drug Administration voted unanimously, with one abstention, that the benefits of the Sapien device outweigh its risks for people who need a new heart valve but face a higher risk of dying from open-heart surgery.

The FDA usually follows panel recommendations, although it is not required to, and will make a final decision in the future.

Shares of Edwards edged up 0.5 percent to $91 in post-market trading, as analysts said a positive recommendation had largely been factored into the share price before the meeting.

The valve is widely considered to be Edwards' most important new product, and was already approved last year for those deemed too sick to have the open-heart surgery.

Devices like Sapien, as well as sophisticated non-surgical techniques, are seen as the next frontier in the battle against heart disease as drugmakers produce fewer new medicines to fight the world's leading cause of death.

The Sapien device is meant for people with aortic stenosis, when the aortic valve that allows blood to leave the heart does not fully open, decreasing blood flow and potentially preventing it from reaching the brain and the rest of the body.

About 250,000 Americans have severe symptoms of the disease, and about two-thirds of them undergo surgery to treat it.

A bad aortic valve commonly requires open-heart surgery, during which the ribs are sawed open, the heart is stopped and a new valve is sewn in place. But thousands of people each year are considered too sick to get the surgery, or have other health conditions that make it risky.

With an Edwards' Sapien transcatheter heart valve -- the first such device in the United States -- a catheter guides the new valve to the heart through the femoral artery in the groin or a small incision between the ribs. The valve costs about $30,000 and is made of cow tissue and polyester supported with a stainless steel mesh frame.

Doctors say this and a similar device being developed by Medtronic Inc will eventually become the standard of care.

In pivotal clinical trials, Edwards said the Sapien led to a slightly lower death rate and dramatically shorter recovery times and hospital stays than chest-cracking open-heart surgery.

However, FDA advisers were concerned about higher stroke risk with the device compared to the traditional surgery, as well as an issue known as aortic leakage, when the valve does not seal properly and can send blood back into the heart.

"I think we are in belief that the totality of the data demonstrate a reasonable assurance of safety and efficacy," said Dr. Warren Laskey, the panel chair and a cardiologist at the University of New Mexico School of Medicine.

"There are questions that remain unaddressed, but they don't seem to impede our acceptance of the totality of the data."

The panelists were also worried about clinical trial data that showed people who had the device inserted through the ribs -- known as a transapical procedure -- had a higher mortality rate after one year compared to an insertion through an artery in the leg.

The advisory panel voted 10 to 2 that the device was safe, and 12 to 0 that it was effective.

Sapien is considered to be one of the most important growth drivers for Edwards, especially if the company gets approval for the broader use, potentially doubling the number of eligible patients, analysts say.

Analysts have pegged the worldwide market for transcatheter aortic valves at more than $2 billion a year.

"A broader indication for high-risk patients would enable multi-disciplinary heart teams to choose the approach best suited to their patients' needs, including for the first time a transapical delivery option," Edwards' chairman and chief executive Michael Mussallem said in a statement.

(Reporting by Anna Yukhananov; Editing by Bernard Orr)

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